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CompletedNCT03722992Updated Jul 23, 2020

The Effects of Mindfulness-based Stress Reduction in Interstitial Cystitis Patients

An interventional study of MBSR in Interstitial Cystitis, sponsored by TriHealth Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-23.

Sponsored by TriHealth Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

This is a prospective cohort study to investigate differences in the bladder environment (i.e. urinary microbiome) amongst women with interstitial cystitis (IC) before and after undergoing mindfulness-based stress reduction (MBSR) treatment, including yoga and meditation practices.

Read the detailed description

Interstitial cystitis (IC), or Painful Bladder Syndrome (PBS) is a debilitating condition of the bladder that is estimated to affect 3-8 million women in the United States. The pathophysiology of the disease is poorly understood, and thus treatment modalities and treatment efficacy vary widely. Lately, much attention has shifted toward investigating how the bladder 'environment' differs amongst women with IC compared to those who do not suffer from IC.

Mindfulness-based stress reduction (MBSR), a complementary alternative medicine (CAM)-based therapy, is a standardized program including components of meditation and yoga. Recent studies show that MBSR improves symptoms in the IC patient population.

The purpose of this study is to compare measurable differences in the urinary microbiome among women with IC before and after MBSR treatment.

02

Conditions studied

  • Interstitial Cystitis
03

In context

Cystitis

235 studies on the registry are indexed under Cystitis; 22 are open to participants now.

This study's enrollment of 14 is below the median of 60 across 170 interventional studies indexed under Cystitis.

Browse Cystitis studies →

Lead sponsor

TriHealth Inc. is the lead sponsor of 99 studies on the registry; 9 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Adults 18 years of age or older
  • English-speaking
  • Established patient of Cincinnati Urogynecology Associates, TriHealth Inc.
  • Current diagnosis of IC/PBS, as defined by the American Urological Association (AUA)
  • Negative urinalysis or urine culture within 2 months of enrollment
  • Currently undergoing first or second-line treatment for IC, as defined by the AUA
  • Willingness to participate in study

Exclusion criteria

Exclusion Criteria:

  • Non-English speaking
  • Unwillingness to participate in study
  • Pregnancy or breastfeeding
  • Physical or mental impairment that would affect the subject's ability to participate in the MBSR treatment, including patients with Dementia, Parkinsonism, or those who have impaired mobility or hearing
  • Current or expected prolonged catheterization
  • Expected travel or surgery that would hinder the ability to attend all eight MBSR sessions
  • Undergoing third-, fourth-, fifth-, or sixth-line treatment for IC as defined by the AUA
  • Subjects on antibiotics currently or prior use within one week of consenting
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Other
    Mindfulness Cohort

    Mindfulness-based stress reduction (MBSR) treatment group

    Other: MBSR

Interventions

  • OtherMBSR

    Guided yoga and meditation practices

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What researchers measure

Primary outcomes

  1. Difference in the urinary microbiome before and after MBSR treatment

    Urinary microbiome sequencing analysis will be performed by Resphera Biosciences Laboratory

    Time frame: Before intervention and after completion of the intervention, up to 9 weeks

07

Study locations

1 site
  • TriHealth - Cincinnati Urogynecology Associates
    Cincinnati, Ohio 45220, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03722992
Lead sponsor
TriHealth Inc.
Responsible party
Sponsor
First posted
Oct 29, 2018
Start date
Mar 7, 2019
Primary completion
Jan 15, 2020
Completion
Mar 15, 2020
Last update
Jul 23, 2020

Study contacts

Rachel Pauls, MD
principal investigator · TriHealth - Cincinnati Urogynecology Associates

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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